Business

Hands-On Training for Biopharmaceutical Careers: Trainees Gain Practical Experience in Realistic Production Environments

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At the April meeting of the BPI International Summit (25−26 April 2017) delegates were treated to a tour of a new training facility. The Biotech Training Facility is about a 20-minute drive from the Amsterdam airport and located in the Leiden Bioscience Park. The park houses companies that employ ~18,000 life science workers. In addition, the Leiden University and the Leiden Academic Medical Center complement the dynamic high-tech environment that facilitates establishment of such a knowledge and experience center as…

October 20, 2017

Introducing NIIMBL: Accelerating Innovation in Biopharmaceutical Manufacturing

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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) was launched in March 2017 as a cooperative agreement with the National Institute for Standards and Technology (NIST), part of the US Department of Commerce. NIIMBL is one of the newest members of Manufacturing USA, a network of manufacturing innovation institutes through which industry, academia, and government work together to accelerate implementation of advanced manufacturing and develop a trained workforce in several key sectors of ththe US economy. NIIMBL’s mission is…

October 20, 2017

Developments in Antibody–Drug Conjugates: A Discussion with Thomas Ryll of ImmunoGen

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As a major class of emerging therapies, antibody-drug conjugates (ADCs) already have gained the attention of biopharmaceutical researchers and manufacturers because they combine both the precision of monoclonal antibodies and the potency of highly potent drug compounds. A few ADCs already have entered the market, but many more candidates are progressing through industry pipelines. Platform processes are not yet universal (and it remains to be seen whether they ever will be), but major ADC developers are establishing their own with…

September 19, 2017

Transforming Deviation Management

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All biopharmaceutical companies espouse a belief in scientific, risk-based approaches. However, with respect to deviation management systems (DMSs), the industry is falling short of that promise. By and large, companies still use a small-molecule pharmaceutical compliance model that dates back to the 1980s, based on the strategy that all deviations are created equal and require 30-day closure. Most bioprocessors still hold to a default 30-day rule, even though there is no specific regulatory requirement for that time frame. Major or…

September 19, 2017

China’s Biopharmaceutical Companies Target Global Markets

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Global perspectives of China as a major biopharmaceutical supplier have changed over the past decade. In 2008, BioPlan Associates completed its first analysis and directory of the top 60 biopharmaceutical facilities in China (1). Based on findings from our study titled Advances in Biopharmaceutical Technology in China (2), we found that China clearly held the image of a low quality manufacturer of biogeneric products almost exclusively for its domestic market. Further, concerns over intellectual property protection, contracting problems, and management…

September 19, 2017

Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)

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In the current global regulatory environment, management and implementation of postapproval CMC changes often can be unpredictable and inefficient. Timelines for change approval can vary from months to years, depending on regional regulatory procedures. Therefore, the challenge in postapproval lifecycle management is to maintain a constant supply of high-quality product while supporting innovation and continual improvement. This was the premise of the CASSS Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held in Gaithersburg, MD, on 20–21 July 2016. The forum…

September 19, 2017

The Unican Concept: Engineering Dual Capability into Single-Use Vessels

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Use of disposable bioreactors in the biopharmaceutical industry has increased gradually over the past several years in pilot, clinical, and production scale facilities (1–4). Reduced time to market in today’s drug industry has created a need for cost-effective development and production strategies as well as manufacturing flexibility. When compared with traditional stainless steel equipment, disposable bioreactor and mixing systems have smaller space requirements, are portable, and come presterilized to eliminate the need for preuse sterilization procedures such as steam-in-place (SIP).…

September 19, 2017

Polysorbates, Biotherapeutics, and Anaphylaxis: A Review

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Rapidly increasing use of monoclonal antibodies (MAbs) in the treatment of neoplastic, autoimmune, and inflammatory diseases has led to a dramatic increase in hypersensitivity reactions worldwide, complicating the use of MAbs as first-line therapies and limiting patient survival and quality of life (1). The origins of anaphylaxis are not well understood, though its mechanism is fairly straightforward (Figure 1). It is usually attributed to some undefined intrinsic property or properties of a biotherapeutic — despite the fact that biotherapeutic formulations…

September 19, 2017

Emerging Markets: Current Insights into the State of Global Biopharmaceutical Manufacturing

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Opportunities for establishing strong biopharmaceutical capabilities are expanding across the globe. This e-book seeks to encapsulate the current state of emerging markets/countries, tracing key elements above and offering examples to show where (in the world) the biopharmaceutical industry is expanding and securing its footholds. Generally, to succeed in these markets, foreign companies must exercise efficient resource management and control, show creativity and receptiveness to cultural differences, develop new strategies, and manage expectations. Working with local partners can provide access to…

August 31, 2017

Regulation, Analytical, and Process Issues with Leachables: Toward Harmonization for Latin America with Europe and North America

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The pharmaceutical industry follows strict regulations regarding impurities, including process-related leachates. Plastic manufacturers use hydrophobic, nontoxic additives for manufacturing containers for use in the pharmaceutical and food industries. However, some issues about dealing with such impurities are not yet resolved. In developing countries, regulators are working on guidelines to help local companies ensure characterization of impurities. In this exclusive editorial eBook, authors from Mexico describe some issues related to plastic leachables in the context of ongoing efforts to harmonize regulations…

August 23, 2017